Best Practices Spotlight

Best practices help new IRB with accreditation

Use of IRB tools helps with success

Within one year of opening its doors in 2009, Opus IRB of Roswell, GA, had its first research review, and within the last year the independent IRB achieved full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC.

Two chief keys to the IRB's success are that Opus IRB developed and improved its comprehensive standard operating procedures (SOPs) and keeps tracking logs and performance metrics, says Judy Cherry, RN, CCRC, CIP, administrative director of Opus IRB.

"Our IRB is an independent, central IRB that was formed by a group of individuals that together have more than 50 years of experience," Cherry says. "Opus IRB's mission is to ensure that research is conducted ethically and protect the safety and well-being of human participants.

"The IRB's founders have watched the research regulatory process evolve over many years, so when they started their own IRB they immediately decided to achieve the industry's highest quality standard through accreditation," she adds.

The Opus board is comprised of specialties from around the nation, providing a national research perspective and expertise, she says.

"Accrediting early in the game is very unusual, but there was no reason not to," Cherry says. "Since we were developing an IRB we just looked at this as if it was really important to ensure we had everything in place."

Here are some of the best practices, Opus IRB followed:

1. Create a comprehensive set of SOPs.

"The first thing we tackled was the SOPs because our SOPs tell the whole story of the organization," Cherry says. "We made sure all of the regulations were covered."

Also, the SOPs include references and links. So at the place where the SOPs discuss waivers of consent, there is a checklist available to see if the protocol is eligible for a waiver.

During the accreditation process, AAHRPP reviewed the SOPs and made suggestions for changes. For instance, AAHRPP suggested Opus IRB provide greater details about its community outreach program, noting what the IRB staff and board were doing with regard to teaching and speaking to the public about research and human subjects protection, Cherry says.

2. Emphasize checklists and links to tools.

Opus IRB provides a public list of 11 IRB forms and tools, in PDF format, on its website at www.opusirb.org. These are continually being revised and improved, Cherry says.

"We opened them to the public so when investigators are looking at Opus IRB they can look at the forms and know what will be required of them," she says.

Included among the forms is a final closeout report that includes a list of closeout activities with space to add information, such as the date when these occurred. These activities include:

— date of study closure at site;

— date last subject completed study (including all follow-up visits/phone calls);

— total number of subjects consented;

— total number of screen failures;

— total number of subjects completing study;

— total number of subjects withdrawn/early terminated from study.

The final closeout form also has "yes" and "no" check boxes for specific and important questions, including these:

— Have there been any significant protocol deviations that have not previously been reported to Opus IRB?

— Have there been any unanticipated problems involving risks to subjects that have not previously been reported to Opus IRB?

— Have there been any serious adverse events that have not previously been reported to Opus IRB?

— Has the site been audited by the FDA or OHRP since your last report?

A final section on the closeout form relates to audit information. It is completed only if the site has been audited by the Food and Drug Administration.

3. Use tracking logs to collect metrics and generate reports.

AAHRPP and potential clients require reports, and one of the best ways to generate these is by using tracking logs for metrics and data, Cherry suggests.

Tracking logs keep all of the necessary information immediately available. So if a pharmaceutical company is considering having Opus IRB serve as its central IRB for a multisite study, then Cherry quickly can provide the company with performance metrics, including information about the IRB's turnaround time and how far in advance a protocol review needs to be scheduled to be put on the IRB's calendar.

"They're very interested in those things," she says. "Time is money for them, and we always have the information at our fingertips."

The information is useful for making sure investigators have submitted all the necessary credentials, as well.

"We don't need to ask for a signed curriculum vitae or medical license for every single study when an investigator has several studies that have been reviewed," Cherry explains.

The database will let the IRB office know when an investigator's CV on file needs to be updated or when a license is about to expire. It also keeps track of all study amendments so these can be pulled up at the time of the continuing review, she adds.

"The tracking log allows for us to create the annual AAHRPP report quickly," Cherry says. "It is a working document; we don't have to go through every study to find the information."

What precisely does the AAHRPP community outreach standard say?

Here is Standard I-4, in a nutshell

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC, has this section devoted to communication with research participants and community outreach in its accreditation standards:

AAHRPP Accreditation Standards: Domain I: Organization

STANDARD I-4: The Organization responds to the concerns of research participants.

Element I.4.A. The Organization has and follows written policies and procedures that establish a safe, confidential, and reliable channel for current, prospective, or past research participants or their designated representatives that permits them to discuss problems, concerns, and questions; obtain information; or offer input with an informed individual who is unaffiliated with the specific research protocol or plan.

Element I.4.B. The Organization conducts activities designed to enhance understanding of human research by participants, prospective participants, or their communities, when appropriate. These activities are evaluated on a regular basis for improvement.

Element I.4.C. The Organization promotes the involvement of community members, when appropriate, in the design and implementation of research and the dissemination of results.